This double-blind, sham-controlled study sought to investigate the effectiveness of cranial electrotherapy stimulation (CES) for the treatment of bipolar II depression (BD II). After randomization, the active group participants (n = 7) received 2 mA CES treatment for 20 minutes five days a week for 2 weeks, whereas the sham group (n = 9) had the CES device turned on and off. Symptom non-remitters from both groups received an additional 2 weeks of open-label active treatment. Active CES treatment but not sham treatment was associated with a significant decrease in the Beck Depression Inventory (BDI) scores from baseline to the second week (p = 0.003) maintaining significance until week 4 (p = 0.002). There was no difference between the groups in side effects frequency. The results of this small study indicate that CES may be a safe and effective treatment for BD II suggesting that further studies on safety and efficacy of CES may be warranted.

A clinical trial of cranial electrotherapy stimulation for anxiety and comorbid depression.

Anxiety disorders are among the most prevalent mental disorders and are usually treated with medication and/or psychotherapy. When anxiety disorders are accompanied with comorbid depression, this further complicates the treatment process. Medication compliance is a common problem due to adverse side effects and new and effective treatments that have minimal side effects are needed for the treatment of anxiety and depression. This study used a randomized, double-blind, sham controlled design to examine the effectiveness of CES as a treatment for anxiety disorders and comorbid depression in a primary care setting. The study was registered at clinicaltrials.gov, NCT01533415.

METHODS:

One hundred and fifteen participants, age 18 years and over, with a primary diagnosis of an anxiety disorder were enrolled from February 2012 to December 2012 The Hamilton Rating Scale for Anxiety (HAM-A) and the Hamilton Depression Rating Scale17 (HAM-D17) were used for baseline and outcome measures at weeks one, three, and five. Response to treatment was defined as a reduction of ≥50% or more on these measures.

RESULTS:

Analysis of covariance revealed a significant difference between the active CES group and the sham CES group on anxiety (p=0.001, d=0.94) and on depression (p=0.001, d=0.78) from baseline to endpoint of study in favor of the active CES group.

BACKGROUND: Cranial electrotherapy stimulation (CES) is a noninvasive procedure that has been used for decades in the United States to treat anxiety, depression, and insomnia in the general population. Whether CES is an effective treatment for patients with a DSM-IV diagnosis of generalized anxiety disorder (GAD) has not previously been explored. The goal of this study was to evaluate the efficacy of CES in alleviating anxiety in patients with DSM-IV-diagnosed GAD. METHOD:Twelve patients from 29 to 58 years of age with a DSM-IV diagnosis of GAD were enrolled from August 2005 to March 2006 through the University of California, Los Angeles (UCLA) Anxiety Disorders Program. Cranial electrotherapy stimulation treatment was administered for 6 weeks using the Alpha-Stim Stress Control System at 0.5-Hz frequency and 300-muA intensity. The primary efficacy measures were the Hamilton Rating Scale for Anxiety (HAM-A) and the Clinical Global Impressions-Improvement (CGI-I) scale. Response to treatment was defined as a reduction of 50% or more on the HAM-A and a CGI-I score of 1 or 2 ("much improved" or "very much improved," respectively). RESULTS: Cranial electrotherapy stimulation was associated with a significant decrease in HAM-A scores (t = 3.083, p = .01). At endpoint, 6 patients (50% of the intent-to-treat sample and 67% of completers) had a 50% decrease in HAM-A score and a CGI-I score of 1 or 2. One additional patient significantly improved in anxiety scores but did not meet criteria for response. Adverse events were generally mild in severity, mostly consisting of headache and nausea. CONCLUSION: This preliminary study suggests that CES may reduce symptoms of anxiety in GAD. We hope that these preliminary results will encourage further research to explore the use of CES in clinical settings.

Cranial Electrotherapy Stimulation Review: A Safer Alternative to Psychopharmaceuticals in the Treatment of Depression.

Kirsch, D, Gilula, M. Journal of Neurotherapy, Vol. 9(2) 2005

The use of Cranial Electrotherapy Stimulation (CES) to treat depression and anxiety is reviewed. The data submitted to the Food and Drug Administration (FDA) for approval of medication in the treatment of depression are compared with CES data. Proposed method of action, side effects, safety factors, and treatment efficacy are discussed. The results suggest there is sufficient data to show that CES technology has equal or greater efficacy for the treatment of depression compared to antidepressant medications, with fewer side effects. A prospective research study should be undertaken to directly compare CES with antidepressant medications and to compare the different CES technologies with each other.

Cranial electrotherapy stimulation for the treatment of depression.

More prevalent in women than men, clinical depression affects approximately 15 million American adults in a given year. Psychopharmaceuticaltherapy accompanied by psychotherapy and wellness interventions (e.g., nutrition, exercise, counseling) is effective in 80% of diagnosed cases. A lesser known adjunctive therapy is that of cranial electrotherapy stimulation (CES). The major hypothesis for the use of CES in depression is that it may reset the brain to pre-stress homeostasis levels. It is conjectured that the pulsed electrical currents emitted by cranial electrical stimulators affect changes in the limbic system, the reticular activating system, and/or the hypothalamus that result in neurotransmitter secretion and downstream hormone production. While evidence is good for applied research, basic research about the mechanisms of action for CES remains in its infancy. A review of the literature provides an overview of current research findings and implications for clinical mental health practice.

Cranial electrotherapy stimulation (CES): a safe and effective low cost means of anxiety control in a dental practice.

A double-blind placebo-controlled study was performed on 33 randomly selected dental patients to evaluate whether cranial electrotherapy stimulation (CES) is a viable procedure for reducing anxiety during routine dental procedures. The active CES treatment group was significantly less anxious than the placebo group at the conclusion of various dental procedures.

Stress-induced anxiety causes the cells of the human body to produce waveforms in different frequencies than normal. Cranial electrotherapy stimulation (CES) involves the use of bioelectric therapy to reestablish the normal electrical flow in the human body by producing waveforms similar to the body's own in a relaxed state. The authors discuss the outcome of a study which tested the usefulness of CES in regard to relief of anxiety.

The administration of transcranial electric treatment for affective disturbances therapy in alcoholic patients.

In a double blind placebo-controlled investigation it was shown that transcranial electric treatment (TET), comprising the combination of a constant current with a pulse current of square impulses of 70-80 Hz is an effective method to correct affective disturbances (anxiety, depression) in alcoholic patients. The medical effects of TET are accompanied by changes in the metabolism of GABA and monoamines, but not of beta-endorphin, and also by a decrease in the latency of alpha-rhythm appearance after closing of the eyes.

Cranial electrotherapy stimulation as a treatment for anxiety in chemically dependent persons.

Cranial electrotherapy stimulation (CES) is reported to be an effective treatment for anxiety, a major presenting symptom among chemically dependent patients. In this study, 40 inpatient alcohol and/or polydrug users were given CES or sham CES in a double blind design. An additional 20 patients served as normal hospital routine controls. Dependent measures of anxiety were the Profile of Mood States, the Institute for Personality and Ability Testing Anxiety Scale, and the State/Trait Anxiety Index. CES-treated patients showed significantly greater improvement on all anxiety measures than did either control group. There were no differences in response between older and younger patients, or between the primarily drug or alcohol abusers. No placebo effect was found on any of our measures. It is concluded that CES is a clinically significant addition to the treatment regimen for this patient population.

Efficiency of transcranial electrostimulation on anxiety and insomnia symptoms during a washout period in depressed patients. A double-blind study.

In order to test the efficacy of cerebral electrostimulation (electrosleep) as an alternative to drug therapy for the treatment of anxiety and insomnia, we conducted a double-blind study in a sample of 21 depressed inpatients submitted to a 5-day period of drug washout on admission to the psychiatric department. During this withdrawal period, anxiety and insomnia were exacerbated in the placebo group, whereas anxiety decreased and sleep duration improved in the active treatment group, with a divergent evolution during the 5-day washout period. The depressive criteria did not respond differentially to treatment, however. Thus, the effects of this drug washout period are markedly attenuated by cerebral electrostimulation, which is of possible interest in the management of psychotropic drug withdrawal.

Electrosleep: a double-blind clinical study.

A double-blind clinical study evaluating the Russian electrosleep technique is presented. Twenty-two patients, mostly outpatients, with neurotic anxiety and depression were each given a course of five half-hour treatments which were either active or simulated electrosleep. In the simulated electrosleep the electrode leads were not connected to the machine. Under these double-blind conditions patients receiving active treatment showed marked clinical improvement that was significantly greater than that showed by patients receiving placebo treatment. Of the 1I patients receiving active treatment 8 made a marked improvement, 2 made a partial improvement, and 1 showed no improvement. Of the 11 receiving inactive treatment, 1 showed marked improvement, 2 showed partial improvement, and 8 showed no improvement. Average "total clinical ratings" on anxiety, sleep disturbance, and depression fell from 11.3 before treatment to 3.2 following treatment. For the patients receiving inactive treatment, average "total clinical ratings" fell from 12.2 to 9.5. Patients receiving active treatment following inactive treatment responded better than patients receiving inactive treatment but did not respond as well as those who received active treatment first. The explanation for this is not clear, but it may reflect a negative expectation following inactive treatment. Patients may have an expectation of failure and a negative placebo effect when the active treatment follows a week of ineffective treatment.

Cranial Electrotherapy Stimulation (CES) in the treatment of anxiety and other stress-related disorders: a review of controlled clinical trials.

Felice, E. Stress Medicine, VOL. 13: 31-42 (1997)

This CES review covers published and to be published clinical trials in the English language and reported to be controlled in some fashion and completed from January 1963 to January 1996. Cranial electrotherapy stimulation (CES) is defined as the application of low-level pulsed electrical current through skin surface electrodes on the head for the treatment of anxiety and other stress-related disorders. A total of 34 controlled clinical trials concerning the efficacy of CES in the treatment of anxiety and other stress-related disorders were evaluated. Overall the results suggest that CES may be capable of producing significant (p < 0.05) benefit in the short-term symptomatic relief of anxiety and other stress-related disorders. CES may be effective alone and as an adjunct to other conservative measures of treatment. The primary mechanism of action of CES appears to be a direct effect on the brain followed by secondary responses. While adverse effects were reported to occur in less than 3 per cent of patients, it is believed they are substantially underreported. The short- and long-term efficacy, adverse effects, safety and mechanism of action of CES remain to be established in rigorous, well-controlled clinical trials. Results reported in this review suggest that CES warrants further study.

Efficacy of cranial electric stimulation for the treatment of insomnia: a randomized pilot study.

OBJECTIVES: This pilot study examined the potential efficacy of cranial electric stimulation for the treatment of insomnia.

DESIGN: The researchers tested the hypothesis through a randomized, double-blind, and placebo controlled clinical trial. The researchers approached eligible subjects who scored 21 or above on the Pittsburgh Insomnia Rating Scale. The researchers then randomly assigned the subjects to receive either an active or sham device. Each study subject received 60min of active or sham treatment for five days. Following each intervention the subjects completed a sleep log, as well as three and ten days later.

SETTING:The researchers conducted the study among active duty service members receiving mental health care on the Psychiatry Continuity Service (PCS), Walter Reed National Military Medical Center in Bethesda, MD.

MAIN OUTCOME MEASURES:The study's primary outcome variables were the time to sleep onset, total time slept, and number of awakenings as reported by the subjects in the serial sleep logs. The researchers identified a nearly significant increase in total time slept after three cranial electricstimulation treatments among all study subjects. A closer examination of this group revealed an interesting gender bias, with men reporting a robust increase in total time slept after one treatment, decay in effect over the next two interventions, and then an increase in total time slept after the fourth treatment. The researchers speculate that the up and down effect on total time slept could be the result of an insufficient dose of cranialelectric stimulation.

Efficiency of transcranial electrostimulation on anxiety and insomnia symptoms during a washout period in depressed patients a double-blind study.

In order to test the effectiveness of cerebral electrostimulation (electrosleep) as an alternative to drug therapy for the treatment of anxiety and insomnia, we conducted a double-blind study in a sample of 21 depressed inpatients submitted to a 5-day period of drug washout on admission to the psychiatric department. During this withdrawal period, anxiety and insomnia were exacerbated in the placebo group, whereas anxiety decreased and sleep duration improved in the active treatment group, with a divergent evolution during the 5-day washout period. The depressive criteria did not respond differentially to treatment, however. Thus, the effects of this drug washout period are markedly attenuated by cerebral electrostimulation, which is of possible interest in the management of psychotropic drug withdrawal.

Electrosleep therapy: a double-blind trial.

Twenty-eight patients participated in a controlled double-blind study to determine the effectiveness of electrosleep as a treatment modality. To our knowledge this is the first study in the English literature in which the peripheral rhythmic electrical stimulation has been eliminated, thereby allowing the results of the current effect on the brain to be independently evaluated. Both global ratings by patients and physicians on the fifth day of treatment and on two-week follow-up indicate that current effect is not associated with significant improvement, although patient global ratings on day 5 indicate a trend in this direction. Self-rating scales by patients indicate no significant improvement for anxiety, insomnia, or somatic complaints. Depressive self-rating scales do show a significant improvement on day 5 of treatment, but no carry over effect to the two-week follow-up.

RESEARCH OBJECTIVE: To examine the efficacy of transcranial electrical stimulation a non-invasive method of reducing pain. DESIGN: A randomized, double-blind, placebo-controlled trial. SUBJECTS: A total of 119 patients with chronic pain. METHODS: Patients were treated with either transcranial electrical stimulation or an active placebo device. Short- and long-term follow-ups were evaluated for treatment efficacy with 4 ordinal scale variables: visual analogue scale (pain level), SLEEP (how often does pain disturb sleep), FREQ (frequency of pain) and MED (frequency of use of medications to relieve pain). RESULTS:Pain level decreased significantly in the transcranial electrical stimulation-treated group compared with the active-placebo group 3 weeks after the end of treatment (p = 0.0017 between groups). Other parameters did not demonstrate significant differences. Three months after the end of treatment this effect was maintained and other treatment parameters showed similar improvements. CONCLUSION: Transcranial electrical stimulation is an effective non-invasive method for pain relief. The active placebo device has a powerful effect on reported pain, which diminishes in the long-term. The involvement of possible neural mechanisms is discussed.

The treatment of fibromyalgia with cranial electrotherapy stimulation.

In cranial electrotherapy stimulation (CES), micro-current levels of electrical stimulation are passed across the head via electrodes clipped to the ear lobes. After successful clinical use of CES with fibromyalgia patients in our clinic, it was decided to test these results with a double-blind, placebo-controlled study in which 60 randomly assigned patients were given 3 weeks of 1-hour-daily CES treatments, sham CES treatments, or were held as wait-in-line controls for any placebo effect in the sham-treated patients. Treated patients showed a 28% improvement in tender point scores, and a 27% improvement in self-rated scores of general pain level. The number of subjects rating their quality of sleep as poor dropped from 60% at the beginning of the study to 5%. In addition, there were significant gains in the self-rated feelings of well-being and quality of life, plus gains in six stress-related psychological test measures. No placebo effect was found among the sham-treated controls. A theoretical role of CES in affecting the brain''s pain message mechanisms and/or neurohormonal control systems is discussed. It is concluded that CES is as effective as the drug therapies in several trials, with no negative side effects, and deserves further consideration as an additional agent for the treatment of fibromyalgia.

BACKGROUND: Stimulation of the antinociceptive system by noninvasive electrical current from electrodes placed on the head is a renewed method of pain relief. METHODS:We conducted a randomized, double-blind, placebo-controlled study on 20 chronic back pain patients. They were treated with eithertranscranial electrostimulation (TCES) or an active placebo device. Pain level and serum beta-endorphin levels were measured before and after treatment. RESULTS: beta-Endorphin level increased in seven of the ten patients from the treatment group and did not change in eight of ten patients from control group (P = 0.057 between groups). Pain level decreased in eight treated patients and seven control patients (significant decrease for each group, no significant difference between groups). CONCLUSIONS: Transcranial electrostimulation is a nonpharmacologic method of pain relief accompanied or mediated by beta-endorphin release. The comparable degree of the initial clinical response emphasizes the powerful placebo effect on reported pain not mediated by endorphin release. This preliminary study shows that noninvasive electrical stimulation is a safe treatment with a positive effect on beta-endorphin blood levels.

BACKGROUND: Chronic pain is a significant problem for many individuals following spinal cord injury (SCI). Unfortunately, SCI-related neuropathic pain has proven to be largely refractory to analgesic medications and other available treatments. Cranial electrotherapy stimulation (CES) has been effective in managing some types of pain. It involves the application of a small amount of current through the head via ear clip electrodes. OBJECTIVE: Explore the effectiveness of CES for neuropathic pain in persons with SCI and chronic pain. Study design: Multi-site, double-blind, sham-controlled study. PARTICIPANTS: Adults with SCI and chronic neuropathic pain at or below the level of injury were randomized to receive active or sham CES. INTERVENTION: Application of active CES or sham CES 1 hour daily for 21 days. Six-month open-label phase to assess 'as-needed' CES use. OUTCOME MEASURES: Change in pre- to post-session pain ratings as well as change in pain intensity, pain interference, pain quality, pain beliefs and coping strategies, general physical and mental health status, depressive symptomatology, perceived stress, and anxiety pre- to post-treatment. RESULTS: The active group reported a significantly greater average decrease in pain during daily treatments than the sham group (Kruskal-Wallis chi-square = 4.70, P < 0.05). During the 21-day trial, there was a significant group time interaction for only one outcome variable; the active group showed larger pre- to post-treatment decreases in pain interference than the sham group did (F = 8.50, P < 0.01, d = 0.59). CONCLUSIONS: On average, CES appears to have provided a small but statistically significant improvement in pain intensity and pain interference with few troublesome side effects. Individual results varied from no pain relief to a great deal of relief.

The use of cranial electrotherapy stimulation in the management of chronic pain: A review.

Cranial Electrotherapy Stimulation (CES) has a growing history of applications in rehabilitation medicine in the United States dating back to early 1970. As a recognized non-drug treatment of anxiety, depression and insomnia, CES gained its first major application in the field of addiction treatment and rehabilitation. By the mid 1980s research was showing additional important uses of CES in the treatment of closed head injured patients, and in paraplegic and quadriplegic patients. The most recent research is showing CES to be highly effective in the management of chronic pain patients. It may be elevating the pain threshold due to its stress reducing effects when anxiety and depression are reduced below clinical levels. Modern theorists of a pain neuromatrix in the cerebral cortex may provide an additional basis for understanding CES mechanisms in the control of pain related disorders.

Safety and effectiveness of cranial electrotherapy in the treatment of tension headache.

One hundred patients were enrolled in a multicenter double-blind study to evaluate the safety and effectiveness of the Pain Suppressor Unit, a cranial electrotherapy stimulator for the symptomatic treatment of tension headaches. Treatment consisted of extremely low level, high frequency current applied transcranially. Pain scores before and after 20 minute treatments of individual headaches as well as patient and physician global evaluations were the primary efficacy variables. Following use of the active unit, patients reported an average reduction in pain intensity of approximately 35%. Placebo patients reported a reduction of approximately 18%. The difference was statistically significant (p = 0.01). The active unit was rated as moderately or highly effective in 40% by physicians, and in 36% by patients. Both physicians and patients scored the placebo unit moderately or highly effective for only 16%. The difference in ordered outcomes was statistically significant (p = 0.004). Approximately 10% of patients in each group reported at least one minor adverse experience. Cranial electrotherapy stimulation is distinct from TENS, and is safe and often effective in ameliorating the pain intensity of tension headaches. It should be considered as an alternative to the chronic usage of analgesics.

A Study of the Effects of Cranial Electrical Stimulation on Attention and Concentration

There have been several anecdotal accounts that cranial electrical stimulation (CES) enhances attention and the ability to learn new tasks in a normal population, but only one published investigation confirms that CES improves attention using the Alpha Stim CES (Madden and Kirsch, 1987). The purpose of this study was to corroborate the findings of Madden and Kirsch, using more precise measures of attention, such as a Continuous Performance Test (CPT). A pretest and posttest CPT was given to two groups using the LISS CES device. The control group consisted of twenty-one subjects who received the placebo treatment. The experimental group of thirty-one subjects received twenty minutes of CES. Four measures of the CPT show significant gains in attention: Number of Hits, p =.010 Hit RT ISI Change, p =.016, Risk Taking, p =.055; and Attentiveness, p =.054. Based on subjects who demonstrated improvement by one standard deviation on two different measures of the CPT, thirty-one percent of the experimental group improved versus four percent of the control group. The use of CES as a method of increasing attention is a promising area that requires further investigation.

Cranial electrotherapy stimulation in the treatment of stress related cognitive dysfunction, with an eighteen month follow up

This study compared the effects of 3 randomly assigned CES devices (Alpha-Stim, CES Labs, Liss Stimulator) in the treatment of stress related attention deficit disorder (ADD) in 23 children and adults, 9 males, 14 females, 9 – 56 years old (average 30.96) with an average education level of 10.56 years. All had been diagnosed as having generalized anxiety disorder (61%), and/or depression (45%), and/or dysthymia (17%), with 1) difficulty in focusing when attempting cognitive tasks, difficulty in “connecting” when initially focused on a cognitive task, and 3) once connected, having difficulty remaining on task or tracking it. CES treatments were given daily, 45 minutes per day for 3 weeks. All 3 CES devices were effective based on Duncan’s Range test in significantly (P

An 18 month follow up found 18 of the original 23 subjects available to return for testing. Overall, they performed as well or better than in the original study. None of the scoring changes in anxiety or depression between post study and follow up testing were found to be significant. The initial Full Scale I.Q. increase held up over the 18 month period while there was a slight, but significant rise in the Verbal I.Q. score (t = 2.37, df = 17, P>.05) and a similar slight, but significant decrease in the Performance I.Q. (t = 3.75, df = 17, P>.01). The author concluded that this study gives strong support for the clinical use of treating stress related cognitive dysfunction in both children and adults.

Non-Drug Treatments for ADHD: New Options for Kids, Adults, and Clinicians

The prolific use of drugs to treat ADHD stirs heated debate in therapy and parenting circles today. Is this medication really going to improve my son’s symptoms? How best can I help my patient and her parents manage this difficult disorder? Will the side effects of this drug outweigh the benefits? What are my other options? Because ADHD affects every facet of life, from psychosocial development and peer relationships to family dynamics and academic and job performance, the need for better―that is, safer and more effective―treatments is urgent. Here, seasoned clinicians Pat Gerbarg and Richard Brown, known for providing the latest breakthroughs in integrative mental health treatments, draw on over 30 years’ clinical experience to offer a range of scientifically-grounded complementary and alternative treatments -- such as neurofeedback therapy and brain stimulation -- for parents and professionals alike.

The Last 50 years of Cranial Electrotherapy Research

Smith, Ray B PhD

The monograph reports five meta-analyses of Cranial Electrotherapy Stimulation (CES) covering various human clinical trials that have been published in the US scientific literature. Each meta-analysis focuses on a particular treatment indication, as follows: 1. Insomnia: 18 studies, 648 subjects, mean improvement 62% 2. Depression: 18 studies, 853 subjects, mean improvement 47% 3. Anxiety: 38 studies, 1495 subjects, mean improvement 58% 4. Drug abstinence: 15 studies, 535 subjects, mean improvement 60% 5. Cognitive dysfunction: 13 studies, 648 subjects, mean improvement 44% Most of these studies are limited by small samples, heterogeneity of symptoms, and overlap of conditions, which limits their rigorousness and generalizability to specific conditions, though these results may be more reflective of "real world" populations in which comorbidity tends to be the rule rather than the exception. CES appears to be a benign intervention with no serious adverse events.

To clarify the diverse published results of cranial electrostimulation (CES) efficacy, we conducted an extensive literature review that identified 18 of the most carefully conducted randomized controlled trials of CES versus sham treatment. For the 14 trials that had sufficient data, we used the techniques of meta-analysis to pool the published results of treating each of four conditions: anxiety (eight trials), brain dysfunction (two trials), headache (two trials), and insomnia (two trials). Because studies utilized different outcome measures, we used an effect size method to normalize measures which we then pooled across studies within each condition. The meta-analysis of anxiety showed CES to be significantly more effective than sham treatment (p < .05). Pooling did not affect results that were individually positive (headache and pain under anesthesia) or negative (brain dysfunction and insomnia). Most studies failed to report all data necessary for meta-analysis. Moreover, in all but two trials, the therapist was not blinded and knew which patients were receiving CES or sham treatment. We strongly recommend that future trials of CES report complete data and incorporate therapist blinding to avoid possible bias.

Is Transcranial Electrical Stimulation (TCES) a safe intervention for children with Cerebral Palsy?

We tested the safety of transcranial electrical stimulation (TCES) applied to seven children (age range 2.5 to 7.5 years) with a confirmed diagnosis of cerebral palsy (CP). Adverse responses were assessed by negative changes in the gross motor function measure test (GMFM), the popliteal angle, and the occurrence of any undesired systemic responses such as seizure, nausea, vomiting, or sleep disruption. The tests first were given before the commencement of a physical therapy exercise (PTE) program combined with a home program of TCES. The tests were repeated after 8 weeks of PTE + TCES and once again after an additional 8 weeks of PT + TCES. One of the 8- week periods involved placebo stimulation in a double-blind design. Stimulator amplitude was 0.5 mA of peak current, phase charge was 0.0166 C, and the averaged RMS current was 249 microamperes. This level was below threshold of sensory nerve excitation, and the child did not perceive the stimulation. Electrodes were placed over the right and left temporal areas of the skull. The stimulation was applied by the parents for 10 minutes, twice a day, 7 days each week. The total goal GMFM scores were greater after both active and placebo stimulation. The popliteal angle improved irrespective of the stimulation intervention. No adverse systemic responses were reported. These results support the hypothesis that TCES as used in this study is a safe procedure.

OBJECTIVES:The use of noninvasive cortical electrical stimulation with weak currents has significantly increased in basic and clinical human studies. Initial, preliminary studies with this technique have shown encouraging results; however, the safety and tolerability of this method of brain stimulation have not been sufficiently explored yet. The purpose of our study was to assess the effects of direct current (DC) and alternating current (AC) stimulation at different intensities in order to measure their effects on cognition, mood, and electroencephalogram. METHODS:Eighty-two healthy, right-handed subjects received active and sham stimulation in a randomized order. We conducted 164 ninety-minute sessions of electrical stimulation in 4 different protocols to assess safety of (1) anodal DC of the dorsolateral prefrontal cortex (DLPFC); (2) cathodal DC of the DLPFC; (3) intermittent anodal DC of the DLPFC and; (4) AC on the zygomatic process. We used weak currents of 1 to 2 mA (for DC experiments) or 0.1 to 0.2 mA (for AC experiment). RESULTS: We found no significant changes in electroencephalogram, cognition, mood, and pain between groups and a low prevalence of mild adverse effects (0.11% and 0.08% in the active and sham stimulation groups, respectively), mainly, sleepiness and mild headache that were equally distributed between groups. CONCLUSIONS: Here, we show no neurophysiological or behavioral signs that transcranial DC stimulation or AC stimulation with weak currents induce deleterious changes when comparing active and sham groups. This study provides therefore additional information for researchers and ethics committees, adding important results to the safety pool of studies assessing the effects of cortical stimulation using weak electrical currents. Further studies in patients with neuropsychiatric disorders are warranted.

This pilot program was designed to determine if using CES affected retention rates among new drug rehab patients arriving at Phoenix House, the nations largest non-profit drug rehab center. The study included 392 subjects consisting of heroin and cocaine addicts; 293 patients did not receive CES (control) and 99 patients received an average of 5 CES treatments total per patient. A 50% increase in retention after 90 days was seen among patients who received CES versus patients who did not receive CES. Patients who received CES also reported significant decreases in anxiety and insomnia. Phoenix House pilot program poster (link to poster, previous file in dropbox.)

Electrostimulation: addiction treatment for the coming millennium.

At a period of fundamental review of the health care system, it is timely to re-assess one of medicine's most intractable problems--the treatment of addictions. The apparently insoluble dilemmas posed by the acute and chronic withdrawal syndromes underlie universally high drop-out and relapse rates. In a decade of HIV and AIDS infection, poly-substance addiction, potent street drugs, and ossified treatment strategies, it is urgent that policy formulators investigate seriously a flexible system of non-pharmacological transcranial electrostimulation treatment, based on its record of rapid, safe, and cost-effective detoxification in several countries, as one innovative contribution to the challenges presented by addiction in the 1990s. This is a brief report of the introduction of NeuroElectric Therapy (NET) into Germany, describing the responses of the first 22 cases. The daily progress of a heroin addict and a methadone addict are detailed: both were treated as outpatients for 8 hours daily, for 7 and 10 days respectively.

Effects of cerebral electrical stimulation on alcoholism: a pilot study.

Cerebral electrical stimulation (CES), born from research on electroanesthesia in the seventies, consists of the application of a pulsating current of small intensity (usually less than 1 mA, and below the threshold of perception) through the skull, e.g., in daily 30-min sessions. Claims of biological effectiveness (neurochemical, hormonal and EEG changes, naloxone-reversible analgesia in rats, etc.) and of clinical effectiveness (anxiety, depression, cognitive functions in alcoholics) have often relied on poorly controlled data. A recent controlled study in the treatment of opiate withdrawal has been positive. The present double-blind controlled study compares active CES with sham stimulation in 64 alcohol-dependent males. Over 4 weeks, both treatment groups improved significantly in most aspects. In the active treatment group additional significant improvement was observed in week-end alcohol consumption, and in two psychological measures: depression and stress symptoms index, but not in general drinking behavior.

The administration of transcranial electric treatment for affective disturbances therapy in alcoholic patients.

In a double blind placebo-controlled investigation it was shown that transcranial electric treatment (TET), comprising the combination of a constant current with a pulse current of square impulses of 70-80 Hz is an effective method to correct affective disturbances (anxiety, depression) in alcoholic patients. The medical effects of TET are accompanied by changes in the metabolism of GABA and monoamines, but not of beta-endorphin, and also by a decrease in the latency of alpha-rhythm appearance after closing of the eyes.

Transcutaneous electrostimulation is a somewhat controversial technique used in the management of the opiate withdrawal syndrome. We report an animal study of a particular transcutaneous electrostimulation called transcutaneous cranial electrostimulation, based on a technique used for many years on heroin addicts for the rapid severance of their addiction, which has been validated in a clinical setting by a double-blind trial. This technique involves the application of an intermittent high-frequency current (Limoge's current). Our experimental data show that this transcutaneous cranial electrostimulation increases morphine analgesia by threefold on the tail flick latency measure and produces a 48% attenuation of the abstinence syndrome observed after abrupt cessation of morphine administration. These results were obtained using a double-blind paradigm.

Treatment of drug, alcohol and nicotine addiction by neuroelectric therapy: analysis of results over 7 years

Patterson MA, Firth J, Gardiner R. J Bioelectricity 1984; 3:193-221

NeuroElectric Therapy (NET) is a 10-day treatment with a transistorized stimulator, which rapidly reduces both acute and chronic withdrawal symptomatology of all chemical substances, without drugs and with no negative side-effects. It is hypothesized that NET acts by specific electrical frequency stimulation of endorphin production that has been decreased due to chronic substance abuse. This has been demonstrated using NET in rat models; corticosterone levels and hepatic enzyme activity were also significantly altered. Of 186 patients, 98.4% were successfully detoxified, with marked feeling of well-being and no craving (in 95%) or anxiety (in 75%). Detailed assessments of abstinence syndrome in NET are given. Of a 50% response to follow-up, 78.5% were addiction-free (80.3% of drug addicts) 1 to 8 years after NET, although average time in rehabilitation was only 16 days. Alcohol, marijuana and cigarette use were decreased in 64%. Diminished substance use was reported in 76% of recidivists.

Several studies have shown that cranial electrotherapy stimulation (CES) is useful in treating brain dysfunction associated with alcoholism. A double-blind study replicated the latest of these findings in 60 inpatients and extended them by treating individuals with alcoholism and other chemical dependencies. Treatment effects were assessed on three subscales of the WAIS that are clinical indicators of organic brain syndrome. No placebo effect was found. CES appears to be a valuable adjunct to rehabilitation programs for addicted persons and can effect changes in areas not addressed by other treatment modalities.

Electrosleep (electrical transcranial stimulation) in the treatment of anxiety, depression and sleep disturbance in chronic alcoholics.

Employed a double-blind design with treatment variables of current and suggestion, and outcome criteria of anxiety, depression, and sleep disturbance to test for effects of electrosleep (electrical transcranial stimulation) in 20 male hospitalized alcoholics (mean age, 51 yrs). Ss were randomly assigned to 1 of 4 groups; 2 groups received current and 2 did not; 1 current and 1 noncurrent group received sensation, the other 2 did not. Current was standardized at 1 mA; peak-to-peak amplitude was manipulated to control for physical sensation. Five outcome criteria were employed: 3 depression indices, 1 index of anxiety, and 1 index of quality of sleep. Results suggest that electrosleep could have both a direct effect attributable to intracranial current flow and an indirect effect attributable to the psychological influence of suggestion.

The effects of cerebral electrotherapy on short-term memory impairment in alcoholic patients.

Two hundred twenty-seven male alcoholism patients were placed into four therapy and onc control groups. The therapy groups received cerebral electrotherapy (CET) for 40 minutes a day, Monday through Friday for 3 weeks. Groups I and II assisted the therapist in setting the current to just below sensation threshold. Group I via headbands (X = 0.40 mA) and Group II via ear stethoscopes (X = 0.21 mA). Two other groups received 0.10 and 0.20 mA respectively via ear stethoscope electrodes. It was found that CET significantly reduced brain dysfunction in all treatment groups when compared with controls as measured by the Benton Visual Retention Test.

The use of cerebral electrotherapy (CET) in methadone detoxification was studied in 28 patients. Fourteen patients received active CET; the other 14 acted as controls and received either stimulated CET or only methadone detoxification therapy. One patient dropped out of the study. The Taylor Manifest Anxiety Scale and the Hamilton Anxiety Scale were administered before and after the study period. Nine of the patients receiving active CET were drug-free by the end of 8 to 10 days, and all experienced a marked reduction of their symptoms; the control group did not show significant changes. CET was clearly beneficial in the treatment of patients undergoing methadone withdrawal.

The field of non-invasive brain stimulation has developed significantly over the last two decades. Though two techniques of noninvasive brain stimulation--transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS)--are becoming established tools for research in neuroscience and for some clinical applications, related techniques that also show some promising clinical results have not been developed at the same pace. One of these related techniques is cranial electrotherapy stimulation (CES), a class of transcranial pulsed current stimulation (tPCS). In order to understand further the mechanisms of CES, we aimed to model CES using a magnetic resonance imaging (MRI)-derived finite element head model including cortical and also subcortical structures. Cortical electric field (current density) peak intensities and distributions were analyzed. We evaluated different electrode configurations of CES including in-ear and over-ear montages. Our results confirm that significant amounts of current pass the skull and reach cortical and subcortical structures. In addition, depending on the montage, induced currents at subcortical areas, such as midbrain, pons, thalamus and hypothalamus are of similar magnitude than that of cortical areas. Incremental variations of electrode position on the head surface also influence which cortical regions are modulated. The high-resolution modeling predictions suggest that details of electrode montage influence current flow through superficial and deep structures. Finally we present laptop based methods for tPCS dose design using dominant frequency and spherical models. These modeling predictions and tools are the first step to advance rational and optimized use of tPCS and CES.

Non-invasive electrical stimulation of the brain (ESB) modifies the resting-state network connectivity of the primary motor cortex: a proof of concept fMRI study.

An innovative method to obtain fMRI resting-state network maps during non-invasive electrical stimulation of the brain (ESB) was developed and tested. Five healthy volunteers participated in 2 fMRI sessions. In session one, a transcranial direct current stimulator (tDCS) was applied placing the positive electrode (31.5 cm(2)) over the right M1 of the cortex and the negative electrode (31.5 cm(2)) over the left supra-orbital area of the head. In session two, a monophasic pulsed current stimulator (tPCS) was applied using the identical electrode placement. Imaging was performed on a Siemens 3T Tim Trio scanner with a 12-channel head coil. At each session, five consecutive functional scans were obtained: 1) resting-state without stimulation (Rest-1), 2) a motor scan consisting of self-paced, bilateral finger-thumb opposition task, 3) resting-state with ESB (Stim-1), 4) resting-state without stimulation (Rest-2), and 5) resting-state with ESB, replicating Stim-1 (Stim-2). Data were analyzed using AFNI and MATLAB. For motor task fMRI analysis, a general linear model (GLM) determined the voxels in the right and left M1 that were significantly correlated with the motor task paradigm. The resting-state time series from the voxels in the R-M1 were averaged and the resulting time series used as a regressor in a GLM analysis to identify M1 connectivity maps. Connectivity maps were quantified as R(2) values, and then combined to give overlap maps for each of the experimental conditions. Fourier analysis determined the energy in the normalized signal average time courses extracted from L-M1 and R-M1 for each of the resting-state scans. Both tDCS and tPCS lowered the R(2) values and energy of the averaged time course in the right and left M1 ROI. The effect of the tPCS appeared more pronounced and less variable among subjects. Applying non-invasive ESB during fMRI scanning may down regulate the motor cortex's resting-state network connectivity.

Safety and immediate effect of noninvasive transcranial pulsed current stimulation on gait and balance in Parkinson disease.

BACKGROUND: Noninvasive electrical stimulation of the brain (ESB) is being investigated as a valued intervention to enhance motor performance.

OBJECTIVE: To ascertain the safety and ability of transcranial pulsed current stimulation (tPCS) to modulate variables of protective stepping and gait of individuals with Parkinson's disease.

METHOD: Ten patients participated in a pilot study. During the first session, a tPCS delivered current for 20 minutes via a positive electrode placed over the primary motor area (M1). In week 2, participants walked for 20 minutes on a treadmill. In week 3, tPCS and treadmill for 20 minutes were combined. Pre-testing and post-testing of gait and protective stepping were administered, comparing post-intervention (tPCS alone, treadmill alone, tPCS + treadmill) with pre-intervention data. The 3 interventions were compared by calculating the difference between post-intervention and pre-intervention data. A significance level of P < .05 was adopted.

RESULTS: Stride length increased from 102.1 +/- 24.4 to 111.2 +/- 22.1 cm, and gait velocity increased from 0.90 +/- 0.23 to 0.985 +/- 0.19 m/s after tPCS. Treadmill or treadmill + tPCS did not result in changes in the studied gait parameters. The tPCS session increased gait velocity and stride length significantly compared with treadmill or tPCS + treadmill. Overall, the number of steps needed to recover balance decreased after tPCS and tPCS + treadmill.

CONCLUSION: Noninvasive tPCS over the primary motor cortex had no adverse effects on those with long-standing Parkinson's disease and may lead to acute improvement of gait and balance recovery.

A study of the effects of cranial electrical stimulation on attention and concentration.

There have been several anecdotal accounts that cranial electrical stimulation (CES) enhances attention and the ability to learn new tasks in a normal population, but only one published investigation confirms that CES improves attention using the Alpha Stim CES (Madden and Kirsch, 1987). The purpose of this study was to corroborate the findings of Madden and Kirsch, using more precise measures of attention, such as a Continuous Performance Test (CPT). A pretest and posttest CPT was given to two groups using the LISS CES device. The control group consisted of twenty-one subjects who received the placebo treatment. The experimental group of thirty-one subjects received twenty minutes of CES. Four measures of the CPT show significant gains in attention: Number of Hits, p =.010 Hit RT ISI Change, p =.016, Risk Taking, p =.055; and Attentiveness, p =.054. Based on subjects who demonstrated improvement by one standard deviation on two different measures of the CPT, thirty-one percent of the experimental group improved versus four percent of the control group. The use of CES as a method of increasing attention is a promising area that requires further investigation.

Brain stimulation in posttraumatic stress disorder.

Posttraumatic stress disorder (PTSD) is a complex, heterogeneous disorder that develops following trauma and often includes perceptual, cognitive, affective, physiological, and psychological features. PTSD is characterized by hyperarousal, intrusive thoughts, exaggerated startle response, flashbacks, nightmares, sleep disturbances, emotional numbness, and persistent avoidance of trauma-associated stimuli. The efficacy of available treatments for PTSD may result in part from relief of associated depressive and anxiety-related symptoms in addition to treatment of core symptoms that derive from reexperiencing, numbing, and hyperarousal. Diverse, heterogeneous mechanisms of action and the ability to act broadly or very locally may enable brain stimulation devices to address PTSD core symptoms in more targeted ways. To achieve this goal, specific theoretical bases derived from novel, well-designed research protocols will be necessary. Brain stimulation devices include both long-used and new electrical and magnetic devices. Electroconvulsive therapy (ECT) and Cranial electrotherapy stimulation (CES) have both been in use for decades; transcranial magnetic stimulation (TMS), magnetic seizure therapy (MST), deep brain stimulation (DBS), transcranial Direct Current Stimulation (tDCS), and vagus nerve stimulation (VNS) have been developed recently, over approximately the past twenty years. The efficacy of brain stimulation has been demonstrated as a treatment for psychiatric and neurological disorders such as anxiety (CES), depression (ECT, CES, rTMS, VNS, DBS), obsessive-compulsive disorder (OCD) (DBS), essential tremor, dystonia (DBS), epilepsy (DBS, VNS), Parkinson Disease (DBS), pain (CES), and insomnia (CES). To date, limited data on brain stimulation for PTSD offer only modest guidance. ECT has shown some efficacy in reducing comorbid depression in PTSD patients but has not been demonstrated to improve most core PTSD symptoms. CES and VNS have shown some efficacy in reducing anxiety, findings that may suggest possible utility in relieving PTSD-associated anxiety. Treatment of animal models of PTSD with DBS suggests potential human benefit. Additional research and novel treatment options for PTSD are urgently needed. The potential usefulness of brain stimulation in treating PTSD deserves further exploration.

The use of cranial electrotherapy stimulation in the treatment of closed-head-injured patients.

This double-blind study sought to discover if cranial electrotherapy stimulation (CES), which is a known treatment of depression, anxiety and insomnia in non-head-injured patients, could be an effective, drug-free treatment of stress-related symptoms in the closed-head-injured (CHI) patient. In this study 10 CHI patients treated for 45 min daily, 4 days a week for 3 weeks, responded significantly on all negative mood factors of the Profile Of Mood States, while five sham-treated and six placebo controls did not. While the majority of the patients were known seizure cases, no patient suffered a seizure during CES therapy. No placebo effects were found, nor were any negative effects from CES treatment seen.

The use of Cranial Electrotherapy Stimulation in the treatment of Multiple Scleroris

The Effect of a Single Cranial Electrotherapy Stimulation on Multiple Stress Measures

Heffernan, M. Townsend Letter for Doctors & Patients. 1995 October.

To assess the post-treatment effects of cranial electrostimulation (CES) on basic psychophysiologic measures of stress response, 20 subjects were chosen from a clinical treatment population of people seeking help for two common stress problems. 0.5 Hz CES was used for muscle tension with pain and essential hypertension made worse by stress. Because few CES studies utilize the common biofeedback measures of finger temperature, heart rate and trapezius electromyogram, these were flagged to be studied before, after, and at one-week follow-up from CES. Also measured, as a dependent variable was capacitance to assess brain circuit paralleling. All dependent measures were found to change significantly when compared to a placebo group. The author strongly recommends CES researchers use more psychophysiologic measures of treatment effects and that some effort be made to understand neuronal path changes resulting from CES.

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